7 results
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26ms
·
Sources: EU EUDAMED, US FDA
GENERATOR, HIGH VOLT, X-RAY, MPX 100
FDA 510(k)
FDA Class 1
·Radiology
THE ASCENSION MOVEMENT GREAT TOE SYSTEM TOTAL ARTHROPLASTY
FDA 510(k)
FDA Unclassified
·Unknown
Solax Electric Scooter (Model: S202261B)
FDA 510(k)
FDA Class 2
·Physical Medicine
TENDRIL SDX
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·May 9, 2014
IMPELLA 2.5
FDA Adverse Event
Malfunction
·ABIOMED·Product code KFM·September 19, 2012
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·ANIMAS CORP·Product code LZG·August 9, 2010
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012